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Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer (PEACE-4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03819101
Recruitment Status : Not yet recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:

This is a 2x2 factorial randomized, multicenter, international, open phase III trial.

The primary objective is to evaluate the benefit of acetylsalicylic acid and atorvastatin on overall survival (OS) (main endpoint) for patients with castrate-resistant prostate cancer starting first line treatment for CRPC


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Acetylsalicylic acid Drug: Atorvastatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1210 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: This is a 2x2 factorial randomized, multicenter, international, open phase III trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2034
Estimated Study Completion Date : March 2038

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
No Intervention: Arm A
Standard of Care (SOC) for CRPC
Experimental: Arm B
SOC + acetylsalicylic acid 100 mg daily
Drug: Acetylsalicylic acid
100mg

Experimental: Arm C
SOC + atorvastatin 80 mg daily
Drug: Atorvastatin
80 mg

Experimental: Arm D
SOC + acetylsalicylic acid 100 mg daily + atorvastatin 8
Drug: Acetylsalicylic acid
100mg

Drug: Atorvastatin
80 mg




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: OS will be calculated from the date of randomization to the date of death up to 15 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate and no curative local therapy considered possible
  • Age ≥ 18 years, life expectancy of at least 6 months
  • CRPC defined as tumor progression (PSA increase on at least 2 separate values separated by at least 1 week or progression on imaging) while on Androgen Deprivation Therapy (orchiectomy, LHRH agonist or -antagonist) with documented serum testosterone levels ≤ 1.7 nmol/L (≤ 0.50 ng/mL). Ongoing concurrent use of LHRH agonist or antagonist is required if the patient has not been surgically castrated
  • Presence (M1) or absence (M0) of metastases on imaging
  • Performance status 0, 1 or 2
  • No previous use of life- prolonging treatments for CRPC (including abiraterone, enzalutamide, radium-223, docetaxel, cabazitaxel, and sipuleucel-T). The use of these agents together with Androgen Deprivation Therapy (ADT) for castrate-sensitive disease is allowed.
  • Adequate renal function within 30 days prior to registration: calculated creatinine clearance ≥ 50 mL/min, according to the formula of Cockcroft-Gault and adequate liver function with levels of AST and ALT ≤ 3xULN and no signs for cholestasis.
  • Participation in other clinical trials is allowed except for trials with the same primary endpoint, i.e. OS
  • Patient authorized to participate to a clinical trial by specific country regulation (eg patient affiliated to a social security system or beneficiary of the same)
  • Information delivered to patient and informed consent form signed by the patient.

Exclusion Criteria:

  • Previous localised malignancy within 2 years with the exception of localized non-melanoma skin cancer and Ta or Tis bladder cancer (patients with asymptomatic Chronic Lymphoïd Leukemia can be included)
  • Previous metastatic malignancy within 5 years
  • Patient currently taking daily acetylsalicylic acid or a daily statin within the last 6 months
  • Patients with active liver disease (hepatitis B or C, cirrhosis) or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal or cholestasis
  • Patients with excessive alcohol intake or history of a relevant liver disease
  • Known hypersensitivity or intolerance to acetylsalicylic acid or atorvastatin or hypersensitivity to any of its components
  • Contra-indication to acetylsalicylic acid or atorvastatin according to label, including known high-risk for haemorrhage,
  • History of or active myopathy or significantly elevated (> 5 times ULN) CK levels
  • History of recent stroke or transient ischemic attack (TIA).
  • Any concomitant drugs contraindicated for use with the trial drugs according to the product information (e.g. Fucidic acid, potent inhibitors of CYP3A4 or transport proteins: ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, tripanavir, telaprevir, saquinavir, darunavir, fosamprenavir, boceprivir, gemfibrozil, fenofibrate, etc)
  • Any serious underlying medical condition (by the investigator's judgement) which could impair the ability of the patient to participate in the trial
  • Patients with hereditary galactose intolerance, Lapp-lactase deficiency or Glucose-Galactose-malabsorption
  • Compliance with trial medical follow-up impossible due to geographic, social or psychological reasons
  • Psychiatric disorder precluding understanding of information about trial related topics, providing informed consent, or interfering with compliance for oral drug intake

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819101


Contacts
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Contact: Karim Fizazi, MD, PhD 0142114317 ext +33 karim.fizazi@gustaveroussy.fr
Contact: Gwenael Le Teuff 0142114955 ext +33 gwenael.leteuff@gustaveroussy.fr

Locations
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France
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val De Marne, France, 94805
Contact: Karim Fizazi, MD, PhD    0142114317 ext +33    karim.fizazi@gustaveroussy.fr   
Contact: Anne Sophie Hue    0142113890 ext +33    anne-sophie.hue@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute, France
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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT03819101    
Other Study ID Numbers: 2017-004639-35
2017/2601 ( Other Identifier: CSET number )
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Aspirin
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Antipyretics